Transcript Related Journal Club Presentation

Journal Club
Alcohol, Other Drugs, and Health: Current Evidence
September–October 2015
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Featured Article
Randomized Controlled
Intervention of the Effects of
Alcohol on Blood Pressure in
Premenopausal Women.
Mori TA, et al. Hypertension. 2015;66(3):517–523.
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Study Objective
• To examine the effects of the administration of
alcohol on premenopausal women’s blood
pressure.
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Study Design
• Randomized controlled trial using a cross-over design in 24
normotensive pre-menopausal women (all of whom had at baseline an
average alcohol consumption of 2–3 standard drinks in a day).
Following a run-in phase, participants were divided into two groups
based on reported average consumption:
• Participants consuming < 200 g alcohol in a week were administered:
– 100 ml/day of red wine on 4 days per week (an average of 46 g/week of alcohol,
about 0.5 drinks per day),
– 200 ml/day of red wine daily (average of 146 g/week of alcohol, about 1.5–2
drinks/day),
– and then similar amounts of dealcoholized red wine consecutively over three 4-week
periods.
• Participants consuming > 200 g alcohol in a week were administered:
– 100 ml/day of red wine daily (an average of 73 g/week of alcohol, about one drink
per day),
– 300 ml/day of red wine daily (218 g/week of alcohol, about 2–3 drinks/day),
– and then similar amounts of dealcoholized red wine consecutively over three 4-week
periods.
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Assessing Validity of an
Article About Harm
• Are the results valid?
• What are the results?
• How can I apply the results to
patient care?
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Are the Results Valid?
• Did the investigators demonstrate similarity in all
known determinants of outcomes? Did they
adjust for differences in the analysis?
• Were exposed patients equally likely to be
identified in the two groups?
• Were the outcomes measured in the same way
in the groups being compared?
• Was follow-up sufficiently complete?
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Did the investigators demonstrate similarity in
all known determinants of outcomes?
• Researchers used a cross-over design in
which participants serve as their own
control.
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Did they adjust for differences in the analysis?
• No, a cross-over design was used in this 12 week
trial with each participant serving as her own
control.
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Were exposed patients equally likely
to be identified in the groups?
• Yes.
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Were the outcomes measured in the
same way in the groups being compared?
• Yes.
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Was follow-up sufficiently complete?
• Yes. All 24 participants completed
the study.
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What are the Results?
• How strong is the association between
exposure and outcomes?
• How precise is the estimate of the risk?
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How strong is the association between
exposure and outcome?
How precise is the estimate of the risk?
• There was a 2±0.6 mm Hg increase
in blood pressure among women
consuming an average of 2-3
standard drinks per day.
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How Can I Apply the Results to
Patient Care?
• Were the study patients similar to the patients
in my practice?
• Was the duration of follow-up adequate?
• What was the magnitude of the risk?
• Should I attempt to stop the exposure?
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Were the study patients similar to the
patients in my practice?
• The participants were healthy,
premenopausal, non-smoking women,
aged 20-45 years who consumed 2-3
drinks per day.
– “They had a body mass index <30 kg/m2 and no
history of hypertension, dyslipidaemia, diabetes
mellitus, liver disease, or coronary, cerebrovascular
or peripheral vascular disease, and were free of
clinical evidence of vascular disease on examination.
They were not taking any medications, including
aspirin, nonsteroidal anti-inflammatory drugs, or the
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oral contraceptive pill.”
Was the duration of follow-up adequate?
• No.
– Alcohol consumption patterns often
persist for years. The three 4-week
study periods provide information about
the short term impact of alcohol
exposure on blood pressure, yet leave
important questions about chronic
exposure unanswered.
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What was the magnitude of the risk?
• “Awake systolic and diastolic BP were 2.3/1.3 mm
Hg higher in women who consumed 146–218 g
alcohol/wk (≈2–3 standard drinks/day) as red wine
for 4 weeks when compared with a similar period
when only dealcoholized red wine was consumed.
There was no effect of lower level alcohol intake
(42–73 g alcohol/week; ≈0.5–1 standard drink/d) to
lower BP.”
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Should I attempt to stop the exposure?
• This is the first study to demonstrate that
alcohol consumption elevates blood pressure
among premenopausal women. Clinicians
should advise their patients of the
cardiovascular risks associated with alcohol
consumption.
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